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Phentermine/Gastric Band Weight Loss Study

Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00771654
Enrollment
0
Registered
2008-10-13
Start date
2009-02-28
Completion date
2010-09-30
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.

Interventions

DRUGPhentermine

Subjects will receive Phentermine 37.5mg everyday for one year

OTHERPlacebo

daily for one year

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult age 18-65 * BMI 35-55 * Approved for gastric band operation

Exclusion criteria

* A known allergy to Phentermine * Take medications for Attention Deficit Disorder (ADD) * Monoamine oxidase inhibitors (MAOI)for depression * Selective serotonin reuptake inhibitor (SSRIs)for depression * History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias * Hyperthyroidism * Glaucoma * Psychosis * History of drug abuse * Uncontrolled hypertension (diastolic \>85)

Design outcomes

Primary

MeasureTime frame
Primary outcomes are total weight loss and excess weightone year

Secondary

MeasureTime frame
Secondary outcomes is resolution of preoperative comorbiditiesone year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026